Donna Kesteven

Experience

• 

  LGC Forensics

  Jun 2010 - May 2011

  Forensic Reporting Officer

  Analysed drugs of abuse, compiled expert witness reports for use as evidence in court.

• 

  Advanced Medical Solutions

  May 2011 - Sept 2014

  Working within new product development to progress projects through once out of approved feasibility.My role surrounds developing the prototype into full scale manufacturing while adhering to all Design Control, Quality and Regulatory standards.Day to day tasks involve protocol/report writing, preparing monthly reports to stakeholders, Microsoft Project, running Project Team Meetings, Risk Management (PFMEA etc) to ISO 14971, updating the project team and Design Control to ISO 13485 standards. Show less

  • Project Scientist

    May 2011 - Sept 2014

  • Technologist

    May 2011 - Apr 2012
• 

  ConvaTec

  Sept 2014 - now

  My role is largely focused around managing life cycle management changes via change control, while ensuring products continue to meet the original design specifications in accordance with Design Control, Quality and Regulatory standards. This requires working with a cross functional team to execute these changes on time and on plan.Day to day tasks involve protocol/report writing, writing Design Control documents to ISO 13485 standards, overseeing and documenting the change control process, managing a team of laboratory staff, providing technical expertise on changes, maintaining project plans, providing updates to senior management. Show less Working with life cycle management of existing projects through change control, while ensuring products continue to meet the original design specifications in accordance with Design Control, Quality and Regulatory standards.Day to day tasks involve data checking, protocol/report writing, statistical assessments using Minitab, writing Design Control documents to ISO 13485 standards, change control processes, overseeing the team of laboratory staff, providing technical expertise on changes. Show less

  • Associate Director Surgical Products R&D

    Sept 2021 - now

  • Senior R&D Manager

    Sept 2019 - Sept 2021

  • R&D Manager

    Nov 2016 - Sept 2019

  • Research Advisor

    Nov 2015 - Oct 2016

  • R&D Scientist

    Sept 2014 - Nov 2015